Oxford Immunotec recalls T-SPOT.TB50 TB test kits due to incorrect expiration dates on labels or substrate components. Affected kits may not be reliable for tuberculosis diagnosis.
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
Oxford Immunotec is recalling T-SPOT.TB50 tuberculosis test kits because the expiration dates on the labels or substrate components are incorrect. This could lead to inaccurate test results if the kits are used after the wrong expiration date.
The test kits have incorrect expiration dates on their labels or substrate components. This means the kits might not be reliable after the expiration date, potentially leading to inaccurate tuberculosis test results.
People who purchased or use T-SPOT.TB50 test kits for tuberculosis diagnosis are affected. Those who have used the kits without verifying the expiration date may have inaccurate results.
Check for the model number T-SPOT.TB50, catalogue number TB.50, and unique device identifier 1505171600004. The kits were sold with specific manufacturing kit lot numbers listed in the recall notice.
Verify the expiration date on the label or substrate component of the test kit. If it appears incorrect, do not use the kit.
The recall is happening because the expiration dates on the labels or substrate components of the T-SPOT.TB50 test kits are incorrect, which could lead to inaccurate tuberculosis test results.
Check the expiration date on the label or substrate component. If it appears incorrect, do not use the kit. Contact Oxford Immunotec for further instructions.
Yes, the affected kits have specific manufacturing kit lot numbers: TFC2481752, TFC2621768, TFC2661790, TFC3081816, TFC3101817, TFC3111818, TFC3111825, TFC2621885, TFC2471883, TFC3361860.
We’ve drafted a message you can send Oxford Immunotec to request your refund or repair — edit it as you like.
Subject: Recall Z-2977-2020 — Oxford Immunotec Oxford Immunotec Hello, I own a Oxford Immunotec that is covered by recall Z-2977-2020 from Oxford Immunotec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
